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Serious Reportable Events In Healthcare—2011 Update: A Consensus Report

Appendix B Glossary

THE FOLLOWING TERMS ARE DEFINED as they apply to the NQF list of serious SFQPSUBCMFFWFOUT5PUIFFYUFOUQSBDUJDBCMF UIFZIBWFCFFOIBSNPOJ[FEXJUIEFmOJUJPOT VTFEJOPUIFS/2'TBGFUZSFMBUFEQSPEVDUT UIF"HFODZGPS)FBMUIDBSF3FTFBSDIBOE 2VBMJUZT$PNNPO'PSNBUT BOEUIF8PSME)FBMUI0SHBOJ[BUJPOTFWPMWJOH*OUFSOBUJPOBM $MBTTJmDBUJPOGPS1BUJFOU4BGFUZ5IF$PNNPO'PSNBUTBSFBQSPEVDUPGUIFSFRVJSFNFOUT of the Patient Safety and Quality Improvement Act of 2005 that provides a structure for SFQPSUJOHBEWFSTFFWFOUT XIJMFUIFMBUUFSQSPWJEFTTUSVDUVSFGPSDMBTTJGZJOHTVDIFWFOUT

B-1 National Quality Forum B - Glossary

t Abduction means the taking away of a person by treatment, rehabilitation, convalescence or other care persuasion, by fraud, or by open force or violence. It of human illness or , physical or mental, including includes convincing someone, particularly a minor or a care during and after pregnancy. Healthcare settings woman he/she is better off leaving with the persuader, include, but are not limited to, hospitals, nursing homes, telling the person he/she is needed, or that the mother or rehabilitation centers, medical centers, office-based father wants him/her to come with the abductor. practices, outpatient dialysis centers, reproductive health t Adverse describes a consequence of care that results in an centers, independent clinical laboratories, hospices, undesired outcome. It does not address preventability. ambulatory surgical centers, and pharmacies. The boundary of a healthcare setting (the “grounds”) is the t means that it is reasonable to initially Associated with physical area immediately adjacent to the setting’s main assume that the adverse event was due to the referenced buildings. It does not include nonmedical businesses such course of care; further investigation and/or root cause as shops and restaurants located close to the setting. analysis of the unplanned event may be needed to confirm or refute the presumed relationship. t High alert are those medications that have a high risk of causing serious injury or death to a patient t means the guardian or other individual(s) Authorized if they are misused. Examples of high-alert medications having the legally recognized ability to consent on behalf include and IV , insulin, of a minor or incapacitated individual (surrogate), or cytotoxic , concentrated electrolytes, IV person designated by the surrogate to release or consent digoxin, opiate narcotics, neuromuscular blocking agents, for the patient. and adrenergic agonists. The recommended “High Alert t Decision-making capacity is the ability to understand List” is available at the Institute for Safe information relevant to a decision and the ability to Medication Practices’ website, http://www.ismp.org. appreciate the reasonably foreseeable consequences of a t Infant is a child under the age of one year. (SRE 2006; decision (or lack of a decision). Stedman’s online dictionary) t Deep tissue injury presents as a purple or maroon localized t Informed consent involves a of shared area of discolored intact skin or blood-filled blister due to decisionmaking in which discussion between a person who damage of underlying soft tissue from pressure and/or would receive a treatment, including surgery or invasive shear. The area may be preceded by tissue that is painful, procedure, and the caregiver/professional person who firm, mushy, boggy, warmer or cooler as compared to explains the treatment, provides information about possible adjacent tissue. benefits, risks and alternatives, and answers questions t Device. See Medical Device. that result in the person’s authorization or agreement to t Elopement refers to a situation where a patient or resident undergo a specific medical intervention. Documentation of who is cognitively, physically, mentally, emotionally, this discussion should result in an accurate and meaningful and/or chemically impaired wanders/walks/runs away, entry in the patient record, which could include a signed escapes, or otherwise leaves a caregiving institution or “consent form.” Signing a consent form does not setting unsupervised, unnoticed, and/or prior to their constitute informed consent; it provides a record of the scheduled discharge. discussion. t Event means a discrete, auditable, and clearly defined t Injury, as used in this report has a broad meaning. It occurrence. includes physical or mental damage that substantially limits one or more of the major life activities of an individual in t Healthcare setting means any facility or office, including a the short term, which may become a disability if extended discrete unit of care within such facility, that is organized, long term. Further, injury includes a substantial change maintained, and operated for the diagnosis, prevention, in the patient’s long-term risk status such that care or

B-2 National Quality Forum Appendix B - Glossary

monitoring, based on accepted national standards, is person becomes a patient at the point that they are being required that was not required before the event. (Of note, “cared for” in the facility. Being “cared for” begins when states and other entities may use alternate definitions for they are first engaged by a member of the care team, e.g. the term “disability.”) assessment by the triage nurse in the E.D., walking with t Largely preventable recognizes that some of the events the phlebotomist to the lab for a lab draw. A patient is on the SRE list are not universally avoidable, given the no longer considered a patient at the point that they are complexity of healthcare and current knowledge. no longer under the care of a member of the care team, e.g. the nursing assistant has safely assisted the patient to t Low-risk pregnancy refers to a woman aged 18-39, the car from an inpatient stay; the ambulating patient that with no previous diagnosis of essential hypertension, does not need assistance leaves the radiology department renal disease, collagen-vascular disease, disease, following an outpatient test.3 cardiovascular disease, previa, multiple gestation, intrauterine growth retardation, smoking, pregnancy- t Pressure , Stage 3 is defined as full thickness tissue induced hypertension, premature rupture of membranes, or loss. Subcutaneous fat may be visible, but , , other previously documented condition that poses a high or muscle is not exposed. Slough may be present. May risk of poor pregnancy outcome. include undermining and tunneling. The depth of a Stage 3 pressure ulcer varies by anatomical location. The bridge t Medical device is an instrument, apparatus, implement, of the nose, , occiput, and malleolus do not have machine, contrivance, implant, in vitro reagent, or other and Stage 3 ulcers can be shallow. similar or related article, including a component part, or In contrast, areas of significant adiposity can develop accessory, which is recognized in the official National extremely deep Stage 3 pressure ulcers. Bone/tendon is Formulary, or the United States Pharmacopoeia, or any not visible or directly palpable.4 supplement to them; intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, t Pressure Ulcer, Stage 4 is defined as full thickness tissue treatment, or prevention of disease, in man or other loss with exposed bone, tendon, or muscle. Slough or animals; or intended to affect the structure or any eschar may be present. Often includes undermining and function of the body of man or other animals, and which tunneling. The depth of a Stage 4 pressure ulcer varies by does not achieve any of its primary intended purposes anatomical location. The bridge of the nose, ear, occiput, through chemical action within or on the body of man and malleolus do not have subcutaneous tissue and these or other animals and which is not dependent upon being ulcers can be shallow. Stage 4 ulcers can extend into metabolized for the achievement of any of its primary muscle and/or supporting structures (e.g., fascia, tendon, intended purposes.1 or ) making or osteitis likely to occur. Exposed bone/tendon is visible or directly palpable.5 t Medication error means any preventable event that may cause or lead to inappropriate medication use or t Pressure Ulcer, Unstageable is defined as full thickness patient harm while the medication is in the control of tissue loss in which the actual depth of the ulcer is the healthcare professional, patient, or consumer. Such completely obscured by slough and/or eschar in the events may be related to professional practice, healthcare wound bed. Until enough slough and/or exchar are products, procedures, and systems, including prescribing; removed to expose the base of the wound, the true depth order communication; product labeling, packaging and cannot be determined; but it will be either Stage 3 or 6 nomenclature; compounding; dispensing; distribution; Stage 4. administration; education; monitoring; and use.2 t Preventable describes an event that could have been t Neonate is a newborn less than 28 days of age. anticipated and prepared for, but that occurs because of an error or other system failure. t Patient means a person who is a recipient of healthcare. A t Restraints is defined by The Joint Commission, the Centers

B-3 National Quality Forum Appendix B - Glossary

for Medicare & Medicaid Services, and by some states. t Surgery ends after all incisions or procedural access routes The appropriate source(s) should be consulted for the have been closed in their entirety, device(s) such as probes definition required by the setting and/or jurisdiction in or instruments have been removed, and, if relevant, final which a presumptive event occurs. In the event none of surgical counts confirming accuracy of counts and resolving those definitions apply to an institution, the following any discrepancies have concluded and the patient has been definition, which is intended to capture definitions taken from the operating/procedure room. from the named organizations, is offered: Restraints t Unambiguous refers to an event that is clearly defined and means any method of restricting a patient’s freedom of easily identified. movement that is not a usual and customary part of a medical diagnostic or treatment procedure to which the t Unintended retention of a foreign object refers to a foreign patient or his or her legal representative has consented; object introduced into the body during a surgical or other is not indicated to treat the patient’s medical condition or invasive procedure, without removal prior to the end of symptoms; or does not promote the patient’s independent the surgery or procedure, which the surgeon or other functioning. practitioner did not intend to leave in the body. t Serious describes an event that can result in death, loss of a body part, disability, loss of bodily function, or require major intervention for correction (e.g., higher level of care, surgery). NOTES t Sexual abuse is defined as the forcing of unwanted sexual 1. Food and Administration. Available at http://www. activity by one person on another, as by the use of threats fda.gov/MedicalDevices/DeviceRegulationandGuidance/ or coercion or sexual activity that is deemed improper or Overview/ClassifyYourDevice/ucm051512.htm Last ac- harmful, as between an adult and a minor or with a person cessed January 19, 2011. of diminished mental capacity. 2. National Coordinating Council for Medication Error Reporting t Surgery is an invasive operative procedure in which skin and Prevention. Available at http://www.nccmerp.org/ or mucous membranes and connective tissue is incised aboutMedErrors.html. Last accessed January 7, 2011. or the procedure is carried out using an instrument that 3. Minnesota Department of Health. is introduced through a natural body orifice. It includes 4. National Pressure Ulcer Advisory Panel. Available at: minimally invasive procedures involving biopsies or http:www.npuap.org/Final_Quick_Treatment_for_ placement of probes or catheters requiring the entry web_2010.pdf . Last accessed January 31, 2011. into a body cavity through a needle or trocar. Surgeries include a range of procedures from minimally invasive 5. National Pressure Ulcer Advisory Panel. Available dermatological procedures (biopsy, excision, and deep at: http:www.npuap.org/Final_Quick_Treatment_for_ web_2010.pdf . Last accessed January 31, 2011. cryotherapy for malignant lesions) to vaginal birth or Caesarian delivery to extensive multiorgan transplantation. 6. National Pressure Ulcer Advisory Panel. Available at: It does not include use of such things as otoscopes and http:www.npuap.org/Final_Quick_Treatment_for_ drawing blood. Organizations may choose to adopt a list web_2010.pdf . Last accessed January 31, 2011. of surgical procedures to supplement the definition above; one example of such a list in common use is that of the Institute of Clinical Systems Improvement. t Surgery begins, regardless of setting, at point of surgical incision, tissue puncture, or insertion of instrument into tissues, cavities, or organs.

B-4 National Quality Forum Serious Reportable Events In Healthcare—2011 Update: A Consensus Report

Appendix C Steering Committee, Technical Advisory Panels, and NQF Staff

Steering Committee Helen Lau, RN, MHROD, BSN, BMus Michael Victoroff, MD Kaiser Permanente Lynxcare Gregg S. Meyer, MD, MSc (Co-chair) Oakland, CA Centennial, CO Massachusetts General Hospital Boston, MA Kathryn J. McDonagh, PhD Hospira Ambulatory and Office-Based Sally Tyler, MPA (Co-chair) Lake Forest, IL Surgery Technical Advisory Panel American Federation of State, County Stancel M. Riley, Jr., MD, MPA, MPH and Municipal Employees John Morley, MD, FACP (Chair) Washington, DC State of New York Department of Health Office of Health Systems Management Massachusetts Board of Registration in Leah Binder Albany, NY Medicine The Leapfrog Group Wakefield, MA Washington, DC Deborah Nadzam, PhD, RN, FAAN Joint Commission Resources, Inc. James P. Bagian, MD Patrick Brennan, MD Westlake, OH Veterans Health Administration University of Pennsylvania Health System Department of Veterans Affairs Philadelphia, PA Martha J. Radford, MD, FACC, FAHA Ann Arbor, MI New York University School of Medicine Tejal Gandhi, MD, MPH New York, NY Leigh Hamby, MD, MHA Brigham and Women’s Hospital Piedmont Healthcare Boston, MA Stancel M. Riley, Jr., MD, MPA, MPH Atlanta, GA Massachusetts Board of Registration in Susan Gentilli, MBA, RHIA, CPHQ Medicine William B. Rosenblatt, MD HealthPartners Wakefield, MA Medical Society of the State of New York Minneapolis, MN New York, NY Diane Rydrych, MA Christine A. Goeschel, RN, MPA Minnesota Department of Health Gina Throneberry, RN, MBA, CASC, Johns Hopkins University School of Medicine St. Paul, MN CNOR Baltimore, MD Symbion Healthcare Doron Schneider, MD, FACP Nashville, TN Kevin P. High, MD, MS Abington Memorial Hospital Wake Forest University School of Medicine Abington, PA Richard Urman, MD, MBA Winston-Salem, NC Harvard Medical School Philip J. Schneider, MS, FASHP Boston, MA Cynthia N. Hoen, Esq, MPH, FACHE University of Arizona College of Pharmacy Atlantic Health Phoenix, AZ Deborah Wheeler Morristown, NJ United HealthCare Eric Tangalos, MD, FACP, AGSF, CMD Las Vegas, NV Mayo Clinic Rochester, MN

C-1 National Quality Forum Serious Reportable Events In Healthcare—2011 Update: A Consensus Report

Appendix C Steering Committee, Technical Advisory Panels, and NQF Staff (cont.)

Physician Office Technical Saul N. Weingart, MD, PhD Gloria J. Jelinek, RN, MSN, JD Advisory Panel Dana-Farber Cancer Institute Kindred Healthcare Boston, MA Louisville, KY Tejal Gandhi, MD, MPH (Chair) Partners Healthcare Elizabeth Wertz Evans, RN James E. Lett, II, MD, CMD Boston, MA PANDA and Associates, LLC American Medical Directors Association Pittsburgh, PA Carmichael,CA Steven Kaplan, MD, FACEP New York Presbyterian Hospital Skilled Nursing Facility Technical Laura M. Wagner, PhD, RN New York, NY New York University College of Nursing Advisory Panel New York, NY Catherine C. Roberts, MD Eric Tangalos, MD, FACP, AGSF, CMD Mayo Clinic (Chair) NQF Staff Phoenix, AZ Mayo Clinic Helen Burstin, MD, MPH Michael A. Steinman, MD Rochester, MN Senior Vice President University of California, San Francisco Debra P. Bakerjian, PhD, MSN, FNP Performance Measures San Francisco, CA Betty Irene Moore School of Nursing Peter Angood, MD Diana Swanson, MSN, NP-C Sacramento, CA Senior Advisor American Academy of Nurse Practitioners Stefan Gravenstein, MD, MPH, CMD Patient Safety Bloomington, IN Quality Partners at Rhode Island Providence, RI Melinda L. Murphy, RN, MS James S. Taylor, MD Clinical Consultant Cleveland Clinic Randall D. Huss, MD Cleveland, OH Lindsey Tighe, MS St. John’s Clinic Research Analyst Rolla, MO

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